Cervical Cancer Clinical Trial
Official title:
Alternate Dosing Schedules Study for HPV Vaccine
The purpose of this study was to determine if delayed dosing of recombinant human
papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls
elicited an equivalent immune response (geometric mean titers to HPV 6,11,16, and 18 as
measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine
delivered according to the recommended dosing schedule.
This was a prospective observational study of healthy 9-18 year old female patients
receiving either a second or third dose of HPV vaccine as part of their well child care.
Immune responses to HPV types 6, 11, 16 and 18 were measured both before and 1 month after
the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV
vaccine when administered at naturally occurring longer dosing intervals to the immune
response to HPV vaccine when administered as routinely recommended.
In addition, girls receiving a 3rd dose of HPV vaccine as well as concomitantly administered
vaccines by injection were randomized to receive either the HPV vaccine first or their
concomitantly administered vaccines first. Pain following vaccination was assessed in each
arm using the Faces Pain Scale - Revised.
Please note: This record refers only to the observational portion of the study. Please refer
to NCT00862810 for the results of the randomized portion of the study.
n/a
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